The LumiGuide Wire is an angiographic guidewire with Fiber Optic RealShape (FORS) technology, intended to direct a catheter in endovascular procedures of the peripheral, aortic side branch vasculature.

The LumiGuide Equipment is a visualization device with Fiber Optic RealShape (FORS) technology intended to aid the positioning and navigation of a connected LumiGuide Wire and, optionally, a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real-time of the connected LumiGuide Wire and, of an endovascular catheter, when combined with a LumiGuide 3D Hub.

The LumiGuide 3D Hub enables the visualization of a connected endovascular catheter, when used in combination with a LumiGuide Wire and the LumiGuide Equipment.

Device Description

The LumiGuide system consists of the following primary devices:

The LumiGuide Wire is a sterile, single use, angiographic quidewire with Fiber Optic RealShape (FORS) technology that is available in two configurations: LumiGuide Navigation Wire 3D Ultra and LumiGuide Navigation Wire 3D Plus. The primary function of the LumiGuide Wire is to direct a catheter in endovascular procedures of the peripheral, aortic and aortic side branch vasculature. The LumiGuide Wire can be visualized in 3D in real time by the LumiGuide Equipment R2.0 using FORS technology.

The LumiGuide Equipment R2.0 is a visualization device with Fiber Optic RealShape (FORS) technology. Its function is to create a real time 3D image of a LumiGuide Wire and, optionally, an endovascular catheter when combined with LumiGuide 3D Hub, and overlay this on real time or prerecorded X-ray images and/or on a pre-operative CT volume. The LumiGuide Equipment R2.0 comprises software and hardware components (such as lasers, optical components, computer hardware, electrical and optical cabling), and a single-use, sterile, detachable component,

The LumiGuide 3D Hub is a sterile, single use accessory to the LumiGuide Equipment R2.0 that connects to the luer connector of endovascular catheters. When the LumiGuide Hub is connected to an endovascular catheter and is used in combination with a LumiGuide Wire, the LumiGuide Equipment R2.0 enables real time 3D visualization of the connected endovascular catheter.

AI/ML Overview

The provided text describes a 510(k) submission for the LumiGuide system, which appears to be an updated version of the existing AltaTrack system. The key takeaway from the document is that the FDA granted a substantial equivalence determination based on non-clinical performance data and a comparison of technological characteristics and indications for use. The document explicitly states that no clinical study data was required or performed for this substantial equivalence determination.

Therefore, there is no information in the provided text regarding acceptance criteria for device performance studies, nor results from such studies (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details). The substantial equivalence was established through non-clinical performance testing.

Here's the breakdown of what can be extracted from the text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document implies that the acceptance criteria were met by demonstrating compliance with applicable international and FDA recognized consensus standards and FDA guidance documents. Specific quantitative criteria are not listed.
Reported Device Performance: Non-clinical performance testing demonstrated that "all executed tests were passed." These tests covered "risk control measures as well as system level requirements, such as dimensional, mechanical and packaging related requirements." Validation testing also covered "intended use, service, user needs, effectiveness of safety measures, instructions for use, and usability testing with representative intended users."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided. No clinical test set was used for substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. Ground truth for a clinical test set was not established as no clinical study was performed for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. No clinical test set was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided. No clinical study, including MRMC, was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not provided. The device (LumiGuide Equipment R2.0) is a "visualization device" intended to "aid the positioning and navigation" of the guidewire/catheter. Its performance in isolation (standalone) in a clinical context was not assessed via a clinical study for this submission. The non-clinical testing covered the functionality of the equipment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance testing, the ground truth would have been established by engineering specifications, validated test methods, and industry standards. The document doesn't detail the specific "ground truth" types for these engineering and usability tests beyond stating compliance with standards.

8. The sample size for the training set

Not applicable/Not provided. This submission does not describe a machine learning or AI algorithm that would require a training set in the typical sense. It is a visualization and navigation aid.

9. How the ground truth for the training set was established

Not applicable/Not provided. (See point 8).

Summary

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March 14, 2024

Philips Medical Systems Nederland B.V. Jeanette Becker Senior Regulatory Affairs Manager Veenpluis 6, 5684 PC Best Netherlands

Re: K233853

Trade/Device Name: LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, DQX Dated: December 5, 2023 Received: December 5, 2023

Dear Jeanette Becker:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Aneesh S. Deoras -S

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality

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Enclosure

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Indications for Use

510(k) Number (if known) K233853

Device Name LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub

Indications for Use (Describe)

The LumiGuide 3D Hub enables the visualization of a connected endovascular catheter, when used in combination with a LumiGuide Wire and the LumiGuide Equipment.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

Date Prepared:	December 5, 2023
Manufacturer:	Philips Medical Systems Nederland B.V.Veenpluis 65684 PC BestThe NetherlandsEstablishment Registration Number: 3003768277
Primary ContactPerson:	Ms. Jeanette BeckerRegulatory Affairs ManagerPhone: +31 621823383E-mail: jeanette.becker@philips.com
Devices:	LumiGuide system, containing the following primary devices:
	Trade Name: LumiGuide WireClassification Name: Catheter guide wireClassification Regulation: 21 CFR, Part 870.1330Device Class: IIProduct Code: DQX
	Trade Name: LumiGuide Equipment R2.0Classification Name: Programmable diagnostic computerClassification Regulation: 21 CFR, Part 870.1425Device Class: IIProduct Code: DQK
	Trade Name: LumiGuide 3D HubClassification Name: Programmable diagnostic computerClassification Regulation: 21 CFR, Part 870.1425Device Class: IIProduct Code: DQK
Predicate Devices:	AltaTrack system (K223918), containing the following devices:
	Trade Name: AltaTrack GuidewireManufacturer: Philips Medical Systems Nederland B.V.Classification Name: Catheter guide wireClassification Regulation: 21 CFR, Part 870.1330Device Class: IIProduct Code: DQK

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K233853

Trade Name:	AltaTrack Equipment R1.2
Manufacturer:	Philips Medical Systems Nederland B.V.
Classification Name:	Programmable diagnostic computer
Classification Regulation:	21 CFR, Part 870.1425
Device Class:	II
Product Code:	DQX
Trade Name:	AltaTrack 3D Hub
Manufacturer:	Philips Medical Systems Nederland B.V.
Classification Name:	Programmable diagnostic computer
Classification Regulation:	21 CFR, Part 870.1425
Device Class:	II
Product Code:	DQK

Device description: The LumiGuide system consists of the following primary devices:

Indications for Use: The LumiGuide Wire is an angiographic guidewire with Fiber Optic RealShape (FORS) technology, intended to direct a catheter in endovascular procedures of the peripheral, aortic and aortic side branch vasculature.
The LumiGuide Equipment is a visualization device with Fiber Optic RealShape (FORS) technology intended to aid the positioning and navigation of a connected LumiGuide Wire and, optionally, a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real-time of the connected LumiGuide Wire and, of an endovascular catheter, when combined with a LumiGuide 3D Hub.

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K233853	PHILIPS	Special 510(k) – 510(k) Summary
		The LumiGuide 3D Hub enables the visualization of a connectedendovascular catheter, when used in combination with a LumiGuide Wireand the LumiGuide Equipment.
	Technologicalcharacteristics:	The basic design and functionality of the LumiGuide Wire has the sametechnological characteristics as its predicate, AltaTrack Guidewire, withexception of the following differences:- the length of the in-body section is changed from 120cm to 160cm.- the LumiGuide Wire is available in two configurations, whereas theAltaTrack Guidewire was only available in one configuration. The onlydifference between the two configurations is that one can alsooptionally be displayed as overlay on a pre-procedural CT volume,same as the AltaTrack Guidewire, whereas the other cannot.The differences between the modified device and the predicate device donot raise any new questions regarding safety or effectiveness.As there are no significant changes to the LumiGuide Equipment R2.0 andthe LumiGuide 3D Hub, their technological characteristics remain the same
		as those of the previous Alta Track branded versions.
	Summary of Non-ClinicalPerformance Data:	Non-clinical performance testing has been performed on the LumiGuideWire (which is also valid for the LumiGuide 3D Hub) and the LumiGuideEquipment R2.0 to cover risk control measures as well as system levelrequirements, such as dimensional, mechanical and packaging relatedrequirements. Results demonstrated that all executed tests were passed.Non-clinical validation testing has been performed to cover the intendeduse, service, user needs, effectiveness of safety measures, instructions foruse, and usability testing with representative intended users.Note that the LumiGuide 3D Hub did not require any additional non-clinicalperformance testing other than the testing performed for the LumiGuideWire.
		The aforementioned non-clinical performance testing demonstratescompliance to the applicable international and FDA recognized consensusstandards and FDA guidance documents.
		Therefore, the LumiGuide system containing the LumiGuide Wire, theLumiGuide Equipment R2.0 and the LumiGuide 3D Hub is consideredsubstantially equivalent to the AltaTrack system containing the AltaTrackGuidewire, the AltaTrack Equipment R1.2 and the AltaTrack 3D Hub interms of safety and effectiveness.
	Summary ofClinicalPerformance Data:	Substantial equivalence of the LumiGuide system containing theLumiGuide Wire, the LumiGuide Equipment R2.0 and the LumiGuide 3DHub did not require clinical study data, since substantial equivalence wasdemonstrated with the following attributes:• Indication for use;• Technological characteristics; and• Non-clinical performance testing.These attributes demonstrated that the clinical performance of the modifieddevice is substantially equivalent to the predicate device.

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Substantial Equivalence Conclusion: Special 510(k) – 510(k) Summary

The LumiGuide system containing the LumiGuide Wire, the LumiGuide Equipment R2.0 and the LumiGuide 3D Hub is considered substantially equivalent to the AltaTrack system containing, the AltaTrack Guidewire, the AltaTrack Equipment R1.2 and the AltaTrack 3D Hub.

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).